A Study of Lasmiditan in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/5/2017 |
| Start Date: | June 16, 2017 |
| End Date: | August 14, 2017 |
Effect of Age on the Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Healthy Subjects
The purpose of this study is to look at the amount of study drug that gets into the blood
stream and how long it takes the body to get rid of it by comparing the results of healthy
elderly participants to those of healthy young participants. The tolerability of the study
drug will be evaluated. Information about any side effects that may occur will also be
collected.
This study will last up to approximately 19 days, not including screening. This study
requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four
days/three nights. Participants will return for a follow-up seven days after last dose of
study drug. Screening is required within 28 days prior to Day 1.
This study is for research purposes only and is not intended to treat any medical condition.
stream and how long it takes the body to get rid of it by comparing the results of healthy
elderly participants to those of healthy young participants. The tolerability of the study
drug will be evaluated. Information about any side effects that may occur will also be
collected.
This study will last up to approximately 19 days, not including screening. This study
requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four
days/three nights. Participants will return for a follow-up seven days after last dose of
study drug. Screening is required within 28 days prior to Day 1.
This study is for research purposes only and is not intended to treat any medical condition.
Inclusion Criteria:
- Are overtly healthy males or females, as determined by medical history and physical
examination.
- Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²)
inclusive, at the time of screening.
Exclusion Criteria:
- Have known allergies to lasmiditan, related compounds or any components of the
formulation.
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
investigator, increases the risks associated with participating in the study.
- Show evidence of active renal disease or estimated glomerular filtration rate (eGFR)
less than 60 milliliter per minute (mL/min) per 1.73 m².
- Show evidence of or positive serology for human immunodeficiency virus (HIV)
infection, hepatitis B or C.
- Are women with a positive pregnancy test or women who are lactating.
- Have a clinically significant abnormality in the neurological examination.
- Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at
risk for falls, as judged to be clinically significant by the investigator.
- Have orthostatic hypotension with or without dizziness and/or syncope at screening or
Day -1 upon repeat testing, or a history of it.
We found this trial at
2
sites
Daytona Beach, Florida 32117
Principal Investigator: Hugh Coleman, MD
Phone: 866-429-3700
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Evansville, Indiana 47710
Principal Investigator: Kelly Whitehurst, MD
Phone: 866-429-3700
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